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Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or
schizoaffective disorder and judged to be stable (without hospitalization or acute
exacerbation and functioning in society) on psychiatric treatment for at least the
past 6 month.

- Current cigarette smokers (at least 15/day during the past year with no period of
abstinence greater than 3 months in the past year) male or female, between the ages of
18 and 75 inclusive, who are motivated to stop smoking.

- Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline
Visits.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- PANSS score >70 at Screen or Baseline Visit.

- Subjects hospitalized within the past six months due to suicidal ideation or suicidal
behavior or subjects considered to have serious suicidal ideation or suicidal behavior
within the past six moth.

- Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or
Baseline Visit.

- Subjects taking Bupropion.

NCT00644969
Pfizer
Completed
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder

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[email protected]

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A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.
This is a safety study.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Smoking Cessation
  • Drug: placebo
    Randomization 2:1 treatment to placebo
  • Drug: varenicline (CP-526,555)
    One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
    Other Name: Chantix, Champix
  • Placebo Comparator: Placebo Arm
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    Intervention: Drug: placebo
  • Active Comparator: Treatment Arm
    Intervention: Drug: varenicline (CP-526,555)
Williams JM, Anthenelli RM, Morris CD, Treadow J, Thompson JR, Yunis C, George TP. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 May;73(5):654-60. doi: 10.4088/JCP.11m07522. Erratum in: J Clin Psychiatry. 2012 Jul;73(7):1035.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
April 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a diagnosis (using the SCID-I/P at screening visit) of schizophrenia or schizoaffective disorder and judged to be stable (without hospitalization or acute exacerbation and functioning in society) on psychiatric treatment for at least the past 6 month.
  • Current cigarette smokers (at least 15/day during the past year with no period of abstinence greater than 3 months in the past year) male or female, between the ages of 18 and 75 inclusive, who are motivated to stop smoking.
  • Score 7 or higher on the Contemplation Ladder at the Screening, Week -1, and Baseline Visits.

Exclusion Criteria:

  • PANSS score >70 at Screen or Baseline Visit.
  • Subjects hospitalized within the past six months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past six moth.
  • Subjects having active suicidal ideation or behavior identified at Screen, Week -1, or Baseline Visit.
  • Subjects taking Bupropion.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00644969
A3051072
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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